BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4962237 · Received August 3, 2015

    Report

    Report Number
    2032227-2015-24809
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 12, 2013
    Report Date
    July 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED PRIME DURING BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT. THE INSULIN PUMP PASSED DISPLACEMENT TEST. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE ON THE DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND CRACKED DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER REPORTED THAT THE DEVICE WAS DAMAGED IN A CAR ACCIDENT TWO YEARS PRIOR TO THE CALL. CUSTOMER STATED THAT THE INSULIN PUMP WAS CRACKED ABOVE THE UP ARROW BUTTON. BLOOD GLUCOSE LEVEL A THE TIME OF THE INCIDENT WAS 130 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505585 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR